Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062358) titled 'A study of serological testing methods for cat-scratch disease-related eye disorders: uveitis(optic neuritis and retinitis), Parinaud's syndrome' on Sept. 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokushima University Graduate School

Condition: Condition - Eye Diseases Associated with Scratch Fever (Uveitis [Optic Neuritis and Retinitis], Parinaud's Ocular Gland Syndrome) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the diagnostic accuracy of conventional methods, B. henselae IgM antibodies (IFA) and IgG antibodies (IFA) in cases suspected of cat-scratch disease-related ocular disorders. To investigate whether adding new serological tests, B. henselae IgM antibodies (ELISA) and B. henselae IgA antibodies (IFA), improves diagnostic accuracy. To compare the clinical presentation, ocular findings, treatment course, and visual prognosis between antibody-positive and antibody-negative groups, thereby clarifying the clinical characteristics of cat-scratch disease-related eye disorders. To collect basic data that will contribute to understanding the current status of cat-scratch disease-related eye disorders in Japan. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Additional Blood Sampling for Research Purposes

Eligibility: Age-lower limit - 2 years-old

Gender - Male and Female Key inclusion criteria - Patients presenting with ocular findings consistent with cat-scratch disease uveitis or Parinaud's syndrome. Ocular findings of cat-scratch disease uveitis include optic neuritis, optic disc edema, radial white spots, multiple choroidal infiltrates, serous retinal detachment, vitreous opacities, serous retinal detachment or intraretinal fluid accumulation on OCT, and retinal vasculitis on fluorescein angiography. Ocular findings of Parinaud's syndrome include unilateral conjunctival injection, mucopurulent discharge, granulomatous follicular conjunctivitis, and ipsilateral lymphadenitis.

Patients with a history of contact with cats, dogs, or other animals, or patients for whom the attending physician suspects contact with animals.

Patients aged 2 years or older but under 80 years at the time of obtaining informed consent.

Gender and status, outpatient or inpatient, are not restricted. Patients who have received a thorough explanation regarding participation in this study, and for whom written informed consent has been obtained from the patient or a legal representative. Key exclusion criteria - Patients for whom the period between the onset of ocular findings and the start of the study exceeds 8 weeks. Patients whom the principal investigator or a co-investigator determines to have significant difficulty understanding the study due to dementia or other conditions, and who are unable to make an appropriate decision regarding participation in this study in a manner that best represents their own interests. Patients for whom blood collection is deemed medically inappropriate. Any other patients whom the principal investigator or a co-investigator determines to be unsuitable as study participants. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 28 Day Anticipated trial start date - 2026 Year 10 Month 01 Day Last follow-up date - 2029 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071039

Disclaimer: Curated by HT Syndication.